Senior Quality Engineer

Senior Quality Engineer

AutoStream Global are partnering up with multiple global leaders in the pharmaceutical, medical device and biotechnology industry. This particular company is looking for a Senior Quality Engineer that can be situated in on of their sites in Ireland.

Responsibilities:

• Supervision of Quality Technicians and Quality Engineers.
• Drive and implement process improvements to ensure predictable processes across all product lines.
• Provide effective and responsive QA support to Operations to meet their area's objectives of
• Drive and implement plant wide quality system improvements.
• Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies.
• Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
• Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
• Approval of change requests for product, process, and quality system changes.
• Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols, and reports approval.
• Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirement.
• Support the implementation of Lean Manufacturing across the site.

Qualifications:

• Requires a minimum level 8 relevant Engineering / Science degree
• Excellent interpersonal and communication skills with good leadership abilities.
• Ability to work as part of a team and meet targets/goals efficiently.
• Excellent analytical and problem-solving skills.
• Minimum of 4+ years' experience within the medical device or pharmaceutical manufacturing industry.
• Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.